FAQs about simvastatin in MS

Simvastatin is a small molecule currently in clinical trials for the treatment of multiple sclerosis (MS). The compound is widely approved to lower cholesterol levels and protect from cardiovascular diseases. But it also has anti-inflammatory and neuroprotective effects that may help people with MS.

Simvastatin has shown promising results in a Phase 2 trial involving people with secondary progressive multiple sclerosis, which encouraged the launch of a larger Phase 3 trial in this patient population. Positive results from this larger trial may potentially support an application requesting simvastatin’s approval by the U.S. Food and Drug Administration. It still could take several years before the therapy is approved, however.

Clinical trials of simvastatin in multiple sclerosis have not included patients who were pregnant. According to its label for other indications, simvastatin may cause fetal harm and patients should talk with their healthcare team if they become or plan to become pregnant while on treatment.

Some patients in clinical trials started seeing results after about two years of therapy. In a Phase 2 trial involving people with secondary progressive multiple sclerosis, a daily simvastatin dose of 80 mg lowered brain volume loss by 43% and improved measures of disability two years after starting treatment. Whether significant results can be observed in this population at earlier time points remains unknown.

Weight gain and hair loss were not reported as side effects of simvastatin in multiple sclerosis clinical trials. However, some people who received the medication for other indications — it is approved as a cholesterol-lowering therapy — have experienced hair loss. There also are some isolated reports of weight gain in people receiving this medicine. Patients should talk with their healthcare provider if such events occur.

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